Induction of Donor-Specific Tolerance in Recipients of Live Donor Stem Cell Infusion (Compassionate Use)
Primary Purpose
Renal Failure
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Biological/Vaccine: Enriched Hematopoetic Stem Cell Infusion
Sponsored by
About this trial
This is an expanded access trial for Renal Failure focused on measuring Kidney Transplantation
Eligibility Criteria
Inclusion Criteria:
- Patient must be between the ages of 18 and 65 years and meet the institution's criteria for renal transplantation for end-organ failure
- Patient is receiving first renal transplant
- Patient is receiving a renal transplant only
- The crossmatch is negative between donor and recipient
- Women who are of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours of initiating total body irradiation (TBI) and agree to use reliable contraception for 1 year following transplant
- Potential donors who are women of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours prior to receiving Granulocyte colony-stimulating factor (G-CSF)
- No evidence of donor-specific antibody presently or historically
Exclusion Criteria:
- Clinically active bacterial, fungal, viral or parasitic infection
- Pregnancy
- Clinical or serologic evidence of viral infection which would preclude the recipient from receiving a kidney transplant
- Previous radiation therapy at a dose which would preclude TBI
- Positive crossmatch between donor and recipient
- Evidence for immunologic memory against donor
- BMI >35 or <18
- Re-transplant
- Positive serologies for hepatitis B virus (HBV), hepatitis C virus (HCV), HIV
Sites / Locations
- Northwestern Memorial Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT02051673
First Posted
January 29, 2014
Last Updated
July 15, 2022
Sponsor
Talaris Therapeutics Inc.
Collaborators
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT02051673
Brief Title
Induction of Donor-Specific Tolerance in Recipients of Live Donor Stem Cell Infusion (Compassionate Use)
Official Title
Induction of Donor-Specific Tolerance in Recipients of Live Donor Stem Cell Infusion (Compassionate Use)
Study Type
Expanded Access
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Talaris Therapeutics Inc.
Collaborators
Northwestern University
4. Oversight
5. Study Description
Brief Summary
Four subjects were treated under compassionate use provisions under this study with facilitating cell therapy (FCRx)
Detailed Description
Four subjects were treated under compassionate use provisions under this study with facilitating cell therapy (FCRx) and living donor kidney transplant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
Keywords
Kidney Transplantation
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Biological/Vaccine: Enriched Hematopoetic Stem Cell Infusion
Intervention Description
Enriched Hematopoetic Stem Cell Infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Eligibility Criteria
Inclusion Criteria:
Patient must be between the ages of 18 and 65 years and meet the institution's criteria for renal transplantation for end-organ failure
Patient is receiving first renal transplant
Patient is receiving a renal transplant only
The crossmatch is negative between donor and recipient
Women who are of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours of initiating total body irradiation (TBI) and agree to use reliable contraception for 1 year following transplant
Potential donors who are women of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours prior to receiving Granulocyte colony-stimulating factor (G-CSF)
No evidence of donor-specific antibody presently or historically
Exclusion Criteria:
Clinically active bacterial, fungal, viral or parasitic infection
Pregnancy
Clinical or serologic evidence of viral infection which would preclude the recipient from receiving a kidney transplant
Previous radiation therapy at a dose which would preclude TBI
Positive crossmatch between donor and recipient
Evidence for immunologic memory against donor
BMI >35 or <18
Re-transplant
Positive serologies for hepatitis B virus (HBV), hepatitis C virus (HCV), HIV
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne T Ildstad, MD
Organizational Affiliation
Talaris Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Induction of Donor-Specific Tolerance in Recipients of Live Donor Stem Cell Infusion (Compassionate Use)
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